dsj-2016-07 attune® cementless cr rp japan

Conditions: Osteoarthritis

Summary: the primary objective is to investigate the change from pre-operative baseline to two year postoperative functional performance improvement for the attune® primary, cementless tka rp system as measured with the koos questionnaire (koos-adl sub-score) in the japanese patient population.

* evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: pkip (overall and sub-scores), koos (overall and sub-scores), aks and eq-5d-3l. * evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified vas pain score (discrete numbers rather than a continual scale) at 2yr. * evaluate type and frequency of adverse events * evaluate survivorship of the attune® primary cementless tka system for the cr rp configurations using kaplan-meier survival analysis at 1 and 2yrs. * evaluate primary, cementless attune® tka fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 1yr, and 2yrs after surgery. * evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs. * radiographically characterize the postoperative attune patellar component alignment and positioning in japanese population.

Eligibility criteria:
inclusion criteria: * subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive. * subject was diagnosed with nidjd. * subject, in the opinion of the investigator, is a suitable candidate for cementless primary tka using the devices described in this cip with either resurfaced or non-resurfaced patellae. subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the sponsor . * subject is currently not bedridden * subject, in the opinion of the investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. * subject is able to read, and comprehend the informed consent document as well as complete the required pros in japanese. exclusion criteria: * the subject is a woman who is pregnant or lactating. -contralateral knee has already been enrolled in this study * subject had a contralateral amputation. * previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary tka in affected knee. * subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive tka. * subject has participated in a clinical investig ation with an investigational product (drug or device) in the last three (3) months. * subject is currently involved in any personal injury litigation, medical-legal or worker's acc ident insurance claims (similar to workers compensation in usa). * subject, in the opinion of the investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported question naires or be compliant with follow-up requirements. * subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. * subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, charcot disease). * subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). * subject has a medical condition with less than two (2) years life expectancy. * uncontrolled gout

Keywords: arthroplasty replacement knee function radiographic survivorship